Notes
to the Financial Statements
(Unaudited)
1.
Business Overview
We
are a U.S.-based biopharmaceutical company specializing in the commercialization of pharmaceutical products for the treatment of dermatological
conditions, in particular, diseases caused primarily by exposure to sunlight that results in sun damage to the skin. Our principal licensed
products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a
licensed topical antibiotic for treatment of impetigo, a bacterial skin infection.
Our principal product is Ameluz®,
which is a prescription drug approved for use in combination with our licensor’s medical device, which has been approved by
the U.S. Food and Drug Administration (“FDA”), the BF-RhodoLED® lamp, for photodynamic therapy in the
U.S. for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. We
are currently selling Ameluz® for this indication in the U.S. under an exclusive license and supply agreement (“Ameluz
LSA”) with Biofrontera Pharma GmbH (“Pharma”) dated as of October 1, 2016, as subsequently amended on June 16,
2021 and further amended on October 8, 2021. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and BF-RhodoLED®
for all indications currently approved by the FDA as well as all future FDA-approved indications.
Our
second prescription drug product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial
growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for
the treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes. The approved indication is impetigo, a common skin
infection. It is approved for use in adults and children 2 months and older. We are currently selling Xepi® for this indication
in the U.S. under an exclusive license and supply agreement (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”)
that was acquired by Biofrontera Inc. on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. (“Cutanea”).
Refer to Note 14, Related Party Transactions, for further details.
Liquidity
and Going Concern
We
devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz®, BF-RhodoLED® and
Xepi®. We have historically financed our operating and capital expenditures through cash proceeds generated from our product sales
and proceeds received in connection with the Intercompany Revolving Loan Agreement with our parent, Biofrontera AG. On December 31, 2020,
the Company agreed to convert the outstanding principal balance of the revolving debt in the amount of $47.0 million into an aggregate
of 7,999,000 shares of common stock at a purchase price of $5.875 per share, which was based on our internal assessment and agreement
with our parent, for an aggregate gross capital contribution of $47.0 million.
Since
inception, we have incurred losses and generated negative cash flows from operations. As of December 31, 2020, we had an accumulated
deficit of $41.2 million
and cash and cash equivalents of $8.1
million. As of September 30, 2021, we had an
accumulated deficit of $64.4
million, which is inclusive of a legal settlement liability
of $11.25 million – see Legal Proceedings section in Note 19 for further details,
and cash and cash equivalents of $1.7
million.
We
expect to continue to generate revenue from product sales. We also expect to continue to incur operating losses from significant sales
and marketing efforts in the U.S as we seek to expand the commercialization of Ameluz® and Xepi®. In addition, we
expect to incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel
to support our product commercialization efforts. We also expect to incur additional costs to continue to comply with corporate governance,
internal controls and similar requirements applicable to us as a public company in the U.S.
Our
future growth is dependent on our ability to obtain equity or debt financing. On March 31, 2021, we entered into the Second Intercompany
Revolving Loan Agreement with Biofrontera AG for $20.0 million of committed sources of funds for a two-year term.
On
November 2, 2021, we completed an initial public offering (“IPO”) and issued and sold 3,600,000 units (“Units”),
each consisting of (i) one share of common stock of the Company, par value $0.001 per share (the “Shares”) and (ii) one warrant
of the Company (the “Warrants”) entitling the holder to purchase one Share at an exercise price of $5.00 per Share. In addition,
the underwriters exercised in full their option to purchase up to an additional 540,000 Warrants to cover over-allotments. The Units
were sold at a price of $5.00 per Unit, and the Company estimates the net proceeds from the IPO to be $15.4 million, after deducting
estimated underwriting discounts and commissions and estimated offering expenses payable by the Company.
On November 24 and November 26, 2021, investors
exercised their warrants to purchase a total of 854,000 shares of common stock at an exercise price of $5.00 per share, resulting in
estimated net proceeds of $3.9 million after deducting underwriting discounts and commission.
On November 29, 2021, we entered into a securities
purchase agreement with a single institutional investor for the purchase of 2,857,143 shares of our common stock (or common stock equivalents
in lieu thereof) and warrants to purchase up to an aggregate of 2,857,143 shares of common stock, in a private placement. The combined
purchase price for one share of common stock (or common stock equivalent) and a warrant to purchase one share of common stock is $5.25.
The warrants have an exercise price of $5.25 per share, will be immediately exercisable, and will expire five years from the issuance
date. The gross proceeds from the private placement offering are expected to be approximately $15.0 million. The private offering is
expected to close on or about December 1, 2021, subject to the satisfaction of customary closing conditions.
With
the funds available under the Second Intercompany Revolving Loan Agreement, the net proceeds from the IPO, and the proceeds
from the private placement offering, we will have sufficient funds to support the operating, investing, and financing activities
of the Company through at least twelve months from the date of the issuance of the interim financial statements.
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Financial Statements
The
accompanying unaudited interim financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”)
for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10 of Regulation S-X. The balance
sheet as of December 31, 2020 was derived from the Company’s audited financial statements. These unaudited condensed financial
statements should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended December 31,
2020, included in the Company’s final prospectus for the Company’s initial public offering, as filed with the Securities
and Exchange Commission (the “SEC”) pursuant to Rule 424(b) under the Securities Act of 1933, on November 1, 2021 (“Final
Prospectus”). In the opinion of management, the interim unaudited condensed financial statements reflect all adjustments, consisting
of normal recurring adjustments, necessary for a fair presentation of the Company’s financial position for the periods presented.
The results for the interim periods presented are not necessarily indicative of future results.
The
financial statements are presented in U.S. dollars (“USD”) or thousands of USD.
The
Company’s significant accounting policies are discussed in Note 2—Summary of Significant Accounting Policies within
the notes to financial statements for the year ended December 31, 2020, included in the Company’s Final Prospectus. There have
been no significant changes to these policies during the nine months ended September 30, 2021, except as noted below.
Recently
Issued Accounting Pronouncements
In
December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), amending accounting guidance to simplify the accounting for income
taxes, as part of its initiative to reduce complexity in the accounting standards. The amendments eliminate certain exceptions related
to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition
of deferred tax liabilities for outside basis differences. The amendments also clarify and simplify other aspects of the accounting for
income taxes. The Company adopted ASU 2019-12 on January 1, 2021. The adoption did not have a material impact on the Company’s
financial statements and disclosures for the nine months ended September 30, 2021.
Recently
Issued Accounting Pronouncements Not Yet Effective
In
February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires organizations that lease assets to recognize on
the balance sheet the assets and liabilities for the rights and obligations created by those leases. The new guidance requires that a
lessee recognize assets and liabilities for leases with lease terms of more than twelve months and recognition, presentation and measurement
in the financial statements will depend on the lease classification as a finance or operating lease. In addition, the new guidance will
require disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash
flows arising from leases. The JOBS ACT provides that an emerging growth company can take advantage of an extended transition period
for complying with new or revised accounting standards. This allows us to delay the adoption of this new standard until it would otherwise
apply to private companies. The new standard will be effective for us for fiscal years beginning after December 15, 2021, and interim
periods within fiscal years beginning after December 15, 2022. The Company is currently evaluating the impact of adopting this guidance.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard will be
effective for us on January 1, 2023. The Company is currently evaluating the impact of adopting this guidance.
3.
Acquisition Contract Liabilities
On March 25, 2019, we entered into an agreement
(as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”) to acquire 100% of the shares of
Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho Co, Ltd. owned approximately 29.9% of
our parent, Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH.
The acquisition
of Cutanea has enabled us to market Xepi®, an FDA-approved drug that had been introduced in the US market in November
2018.
After
the date of acquisition, we were entitled to restructure the business of Cutanea and be reimbursed by Maruho for these restructuring
costs. These restructuring costs Maruho agreed to pay are referred to as “SPA Costs” under the arrangement and are to be
accounted for as other income in the period the amounts are determined in accordance with ASC 810. Refer to Note 15, Restructuring
costs, for further detail.
Pursuant
to the Share Purchase Agreement, Maruho agreed to provide $7.3
million in start-up cost financing for Cutanea’s
redesigned business activities (“start-up costs”). These start-up costs are to be paid back to Maruho by the end of 2023
in accordance with contractual obligations related to an earn-out arrangement. In addition, as part of the earn-out arrangement with
Maruho, the product profit amount from the sale of Cutanea products as defined in the share purchase agreement will be shared equally
between Maruho and Biofrontera until 2030 (“contingent consideration”).
In
connection with this acquisition, we recorded: (i) a $4.6
million intangible asset related to the Xepi® license refer, (Refer to Note 9, Intangible Asset, net, for further
detail) (ii) a $1.7
million contract asset related to the benefit associated with the non-interest bearing start-up cost financing, (iii) $6.5
million of contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with
Maruho, (iv) a bargain purchase gain of $5.7
million due to the excess fair value of the net assets acquired over the cash consideration transferred, as well as (v) a favorable
lease asset of $69,000
related to the leased properties. The total fair value of the consideration expected to be transferred from the Company to Maruho
was the one US dollar purchase price and $6.5
million of contingent consideration related to the earn-out.
The
contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0% interest rate over the 57-month
term of the financing arrangement, which ends on December 31, 2023. The start-up cost financing was determined to represent interest
free financing arranged for the benefit of the Company and, as such, was excluded from the purchase consideration. The contract asset
is shown net of the related start-up cost financing within acquisition contract liabilities, net.
The
contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate
of 6.0%
over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The amount of contingent
consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and
re-assesses the underlying assumptions and estimates at each reporting period.
Acquisition
contract liabilities, net consist of the following:
Schedule
of Acquisition Contact Liabilities
(in thousands)
|
|
September 30, 2021
|
|
|
December 31, 2020
|
|
|
|
|
|
|
|
|
Contingent consideration
|
|
$
|
9,300
|
|
|
$
|
7,602
|
|
Start-up cost financing
|
|
|
7,300
|
|
|
|
7,300
|
|
Contract asset
|
|
|
(805
|
)
|
|
|
(1,074
|
)
|
Acquisition contract liabilities, net
|
|
$
|
15,795
|
|
|
$
|
13,828
|
|
Contingent
consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected
at fair value within acquisition contract liabilities, net on the balance sheets. The fair value is based on significant inputs not observable
in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent consideration utilizes
a Monte Carlo simulation model, which incorporates the following key assumptions and estimates: (i) the product profit amount to be shared
equally with Maruho, (ii) remaining contractual term, (iii) risk discount rate, and (iv) payment discount rate of 6.0%. The Company re-measures
contingent consideration and re-assesses the underlying assumptions and estimates at each reporting period.
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule
of Fair Value of Contingent Consideration
(in thousands)
|
|
|
|
Balance at December 31, 2018
|
|
$
|
-
|
|
Issuance of contingent consideration at acquisition date
|
|
|
6,500
|
|
Change in fair value of contingent consideration
|
|
|
962
|
|
Balance at December 31, 2019
|
|
$
|
7,462
|
|
Change in fair value of contingent consideration
|
|
|
140
|
|
Balance at December 31, 2020
|
|
$
|
7,602
|
|
Change in fair value of contingent consideration
|
|
|
1,698
|
|
Balance at September 30, 2021
|
|
$
|
9,300
|
|
The
change in fair value of the contingent consideration is recorded in operating expenses in the statements of operations. The fair value
of the contingent consideration increased $0.7 million and $1.7 million for the three and nine months ended September 30, 2021, respectively.
The fair value of the contingent consideration increased $0.1 million and $0.2 million for the three and nine months ended September
30, 2020, respectively.
4.
Revenue
We
generate revenue primarily through the sales of our products Ameluz®, BF-RhodoLED® lamps and Xepi®.
Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the
revenues generated through our sales of Ameluz®.
Schedule
of Revenue Sales of Products
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
For three months ended
September 30,
|
|
|
For nine months ended
September 30,
|
|
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net
|
|
$
|
4,319
|
|
|
$
|
3,236
|
|
|
$
|
14,890
|
|
|
$
|
10,230
|
|
Related party revenues
|
|
|
15
|
|
|
|
16
|
|
|
|
42
|
|
|
|
47
|
|
Revenues, net
|
|
$
|
4,334
|
|
|
$
|
3,252
|
|
|
$
|
14,932
|
|
|
$
|
10,277
|
|
We
generated $4.3 million and $14.6 million of Ameluz® revenue, de minimus amounts of Xepi® revenue and $73,000
and $0.3 million of BF-RhodoLED® lamps revenue during the three and nine months ended September 30, 2021, respectively.
During
the three and nine months ended September 30, 2020, we generated $3.1 million and $9.7 million of Ameluz® revenue, $54,000
and $0.2 million of Xepi® revenue, and $86,000 and $0.3 million of BF-RhodoLED® lamps.
Related
party revenue relates to an agreement with Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED® leasing
and installation service. Refer to Note 14, Related Party Transactions.
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule of Tabular Disclosure of Revenue Allowance and Accrual Activities
(in thousands):
|
|
Returns
|
|
|
program
|
|
|
discounts
|
|
|
rebates
|
|
|
Total
|
|
|
|
|
|
|
Co-pay
|
|
|
Prompt
|
|
|
Government
|
|
|
|
|
|
|
|
|
|
assistance
|
|
|
pay
|
|
|
and payor
|
|
|
|
|
(in thousands):
|
|
Returns
|
|
|
program
|
|
|
discounts
|
|
|
rebates
|
|
|
Total
|
|
Balance at December 31, 2020
|
|
$
|
217
|
|
|
$
|
52
|
|
|
$
|
15
|
|
|
$
|
43
|
|
|
$
|
327
|
|
Provision related to current period sales
|
|
|
2
|
|
|
|
211
|
|
|
|
6
|
|
|
|
119
|
|
|
|
339
|
|
Credit or payments made during the period
|
|
|
(142
|
)
|
|
|
(263
|
)
|
|
|
(5
|
)
|
|
|
(113
|
)
|
|
|
(523
|
)
|
Balance at September 30, 2021
|
|
$
|
77
|
|
|
$
|
-
|
|
|
$
|
16
|
|
|
$
|
49
|
|
|
$
|
143
|
|
5.
Accounts Receivable, net
Accounts
receivable are mainly attributable to the sale of Ameluz®, the BF-RhodoLED® and Xepi®. It
is expected that all trade receivables will be settled within twelve months of the balance sheet date.
The
allowance for doubtful accounts was $9,000 and $40,000 as of September 30,2021 and December 31, 2020, respectively.
6.
Inventories
Inventories
are comprised of Ameluz®, Xepi® and the BF-RhodoLED® finished products.
In
assessing the consumption of inventories, the sequence of consumption is assumed to be based on the first-in-first-out (FIFO) method.
During the three and nine months ended September 30, 2021, we recorded a $(3,000) and $31,000 provision, respectively, for Xepi®
inventory obsolescence. During the three and nine months ended September 30, 2020, we recorded a $0.4 million and $0.4 million
provision, respectively, for Xepi® inventory obsolescence due to product expiring.
7.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following:
Schedule of Prepaid Expenses and Other Current Assets
(in thousands)
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
$
|
390
|
|
|
$
|
497
|
|
Security deposits
|
|
|
121
|
|
|
|
121
|
|
Other
|
|
|
425
|
|
|
|
498
|
|
Total
|
|
$
|
936
|
|
|
$
|
1,116
|
|
8.
Property and Equipment, Net
Property
and equipment, net consists of the following:
Schedule of Property and Equipment
(in thousands)
|
|
September
30,
2021
|
|
|
December
31,
2020
|
|
|
|
|
|
|
|
|
Computer equipment
|
|
$
|
81
|
|
|
|
74
|
|
Computer software
|
|
|
27
|
|
|
|
27
|
|
Furniture & fixtures
|
|
|
81
|
|
|
|
81
|
|
Leasehold improvement
|
|
|
368
|
|
|
|
368
|
|
Machinery & equipment
|
|
|
106
|
|
|
|
106
|
|
Office equipment
|
|
|
5
|
|
|
|
5
|
|
Property and equipment, gross
|
|
|
668
|
|
|
|
661
|
|
Less: Accumulated depreciation
|
|
|
(379
|
)
|
|
|
(291
|
)
|
Property and equipment, net
|
|
$
|
289
|
|
|
$
|
370
|
|
Depreciation
expense is included in selling, general and administrative expense on the statements of operations. Depreciation expense was $29,000
and $95,000 for the three and nine months ended September 30, 2021, respectively. Depreciation expense was $36,000 and $109,000 for the
three and nine months ended September 30, 2020, respectively.
9.
Intangible Asset, Net
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands)
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
|
|
Xepi® license
|
|
$
|
4,600
|
|
|
$
|
4,600
|
|
Less: Accumulated amortization
|
|
|
(1,045
|
)
|
|
|
(731
|
)
|
Intangible asset, net
|
|
$
|
3,555
|
|
|
$
|
3,869
|
|
The
Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6 million and is amortized on a straight-line
basis over the useful life of 11 years. Amortization expense is included in selling, general and administrative expense on the statements
of operations. Amortization expense for the three and nine months ended September 30, 2021 was $0.1 million and $0.3 million, respectively.
Amortization expense for the three and nine months ended September 30, 2020 was $0.1 million and $0.3 million, respectively. The expected
annual amortization expense for the next five years from 2021 to 2025 is $0.4 million each year.
We
review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be fully recoverable. As of March 31, 2020, given the impact to the global economy, as well as
the Company’s operations, from the COVID-19 pandemic, the Company determined an interim impairment analysis was warranted for the
Xepi® license acquired in the Cutanea business combination. The Company evaluated the Xepi® license for
impairment using an undiscounted cash flow analysis and determined no impairment charge was necessary.
The
Company did not recognize any intangible asset impairment charges during the three and nine months ended September 30, 2021 or 2020.
10.
Statement of Cash Flows
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the statements
of cash flows:
Schedule
of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
(in thousands)
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,716
|
|
|
$
|
8,080
|
|
Short-term restricted cash
|
|
|
47
|
|
|
|
48
|
|
Long-term restricted cash
|
|
|
150
|
|
|
|
150
|
|
Total cash, cash equivalent, and restricted cash shown on the statements of cash flows
|
|
$
|
1,913
|
|
|
$
|
8,278
|
|
11.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consist of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands)
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
|
|
Legal settlement
|
|
$
|
5,625
|
|
|
$
|
-
|
|
Employee compensation and benefits
|
|
|
1,803
|
|
|
|
1,781
|
|
Professional fees
|
|
|
744
|
|
|
|
170
|
|
Product revenue allowances and reserves
|
|
|
143
|
|
|
|
327
|
|
Restructuring liability
|
|
|
63
|
|
|
|
-
|
|
Other
|
|
|
884
|
|
|
|
428
|
|
Total
|
|
$
|
9,262
|
|
|
$
|
2,706
|
|
12.
Other Long-Term Liabilities
Other
long-term liabilities consist of the following:
Schedule of Other Long Term Liabilities
(in thousands)
|
|
September 30,
2021
|
|
|
December
31,
2020
|
|
|
|
|
|
|
|
|
Legal settlement - noncurrent
|
|
$
|
5,625
|
|
|
$
|
-
|
|
Other
|
|
|
23
|
|
|
|
62
|
|
Total
|
|
$
|
5,648
|
|
|
$
|
62
|
|
13.
Income Taxes
As
part of Congress’s response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”),
was signed into United States law on March 27, 2020 and modifies certain provisions of the Tax Cuts and Jobs Act, enacted in 2017, with
respect to net operating losses. Under the CARES Act, the limitation on the deduction of net operating losses to 80% of annual taxable
income is suspended for taxable years beginning before January 1, 2021. The CARES Act did not have a material impact on the financial
statements due to our full valuation allowance position.
As
a result of the net losses we have incurred since inception, we have recorded no provision for federal income taxes during such periods.
Income tax expense incurred for the three and nine months ended September 30, 2021 and 2020 relates to state income taxes.
At
September 30, 2021 and December 31, 2020, the Company had no unrecognized tax benefits.
Interest
and penalty charges, if any, related to unrecognized tax benefits would be classified as income tax expense in the accompanying statements
of operations. As of September 30,2021, and December 31, 2020, the Company has no accrued interest related to uncertain tax positions.
Since the Company is in a loss carryforward position, it is generally subject to examination by the U.S. federal, state, and local income
tax authorities for all tax years in which a loss carryforward is available.
14.
Related Party Transactions
License
and Supply Agreement
On
July 15, 2016, the Company executed an exclusive license and supply agreement with Pharma, which was amended in July 2019 to increase
the Ameluz transfer price per unit from 35.0%
to 50.0%
of the anticipated net selling price per unit
as defined in the agreement. Under the agreement, the Company obtained an exclusive, non-transferable license to use the Pharma’s
technology to market and sell the licensed products, Ameluz® and BF-RhodoLED® and must purchase the licensed
products exclusively from Pharma. There was no
consideration paid for the transfer of the license.
Refer to Note 21 Subsequent Events, for amendment to license and supply agreement dated October 8, 2021.
Purchases
of the licensed products during the three and nine months ended September 30, 2021 were $1.0
million and $5.7
million respectively, and recorded in inventories
in the balance sheets, and, when sold, in cost of revenues, related party in the statements of operations. Purchases of the licensed
products during the three and nine months ended September 30, 2020 were $0.3
million and $5.6
million. Amounts due and payable to Pharma as
of September 30, 2021 and December 31, 2020 were $1.3
million, which were recorded in accounts payable,
related parties in the balance sheets.
Loan
Agreement
On
June 19, 2015, the Company entered into a 6% interest bearing revolving loan agreement with Biofrontera AG, the Company’s parent.
Interest was accrued and paid quarterly over the life of the loan. As of September 30, 2021 and December 31,2020, there was no loan principal
balance outstanding. There was no interest expense recognized for the three or nine months ended September 30, 2021. Interest expense
for the three and nine months ended September 30, 2020 was $0.7 million and $1.9 million, respectively.
On
December 31, 2020, the Company agreed to convert the outstanding principal balance of the revolving debt of $47.0 million into an aggregate
of 7,999,000 shares of common stock at a price of $5.875 per share, for an aggregate gross capital contribution of $47.0 million.
On
March 31, 2021, the Company entered into the Second Intercompany Revolving Loan Agreement with Biofrontera AG for $20.0 million of committed
sources of funds. The revolving loan bears an annual interest rate of 6.0% and will terminate on the second anniversary of the date of
this loan agreement, March 31, 2023 (the “termination date”). The outstanding principal and interest balance of all advances
shall be due and payable on the termination date. In the event of a change in control of the Company at any point prior to the termination
date, Biofrontera AG’s obligation to make advances to the Company shall be discharged immediately upon the effective date of the
change of control; and all outstanding obligations of the Company must be paid back in full within twelve months of the effective date
of the change of control. Biofrontera AG may require the Company to pay all outstanding obligations at any time on or after the date
that is ten calendar days following the closing of a transaction that reduces the voting rights of the Company in Biofrontera AG to less
than 100%. As of September 30, 2021, the Company has not drawn upon the Second Intercompany Revolving Loan Agreement.
Service
Agreements
On
January 1, 2016, the Company executed an intercompany service agreement with Biofrontera AG. Under the agreement, the Company receives
services which include accounting consolidation, information technology support, and pharmacovigilance services.
On
July 2, 2021, we entered into a new intercompany services agreement (“2021 Services Agreement”) which provides for the execution
of statements of work that will supersede the applicable provisions of the 2016 Services Agreement. The 2021 Services Agreement enables
us to continue relying on Biofrontera AG and its subsidiaries for various services it has historically provided to us, including information
technology and pharmacovigilance support. Under the 2021 Services Agreement we have agreed that the applicable provisions related to
reimbursement and allocation of expenses in the 2016 Services Agreement will remain in effect until we execute a statement of work under
the 2021 Services Agreement that supersedes such provisions. Expenses related to the service agreement were $0.2 million and $0.5 million
for the three and nine months ended September 30, 2021, respectively, and $0.1 million and $0.4 million for the three and nine months
ended September 30, 2020, respectively, which were recorded in selling, general and administrative, related party. Management asserts
that these expenses represent a reasonable allocation from Biofrontera AG. Amounts due to Biofrontera AG related to the service agreement
were $0.3 million and $0.3 million as of September 30, 2021 and December 31, 2020, respectively, which were recorded in accounts payable,
related parties in the balance sheets.
Clinical
Lamp Lease Agreement
On
August 1, 2018, the Company executed a clinical lamp lease agreement with Bioscience to provide
lamps and associated services.
Total
revenue related to the clinical lamp lease agreements was approximately $15,000
and $16,000
for the three months ended September 30, 2021
and 2020, respectively and recorded as revenues, related party. Total revenue related to the clinical lamp lease agreements was approximately
$42,000
and $47,000
for the nine months ended September 30, 2021
and 2020, respectively. Amounts due from Bioscience for clinical lamp and reimbursement were approximately $37,000
and $73,000
as of September 30, 2021 and December 31, 2020,
respectively, which were recorded as accounts receivable, related parties in the balance sheets.
Reimbursements
from Maruho Related to Cutanea Acquisition
Pursuant
to the Cutanea Share Purchase Agreement, we received start-up cost financing and reimbursements for certain SPA costs.
Refer to Note 3 - Acquisition Contract Liabilities.
For
the nine months ended September 30, 2020, the Company received start-up cost financing from Maruho in the amount of $3.4 million, which
was recorded as acquisition contract liabilities, net in the balance sheets. No start-up cost financing was received during the nine
months ended September 30, 2021.
The
amounts reimbursed relating to SPA costs were recorded as other income in the statements of operations as the related expenses were recorded.
For the three and nine months ended September 30, 2021, the reimbursed amounts recognized relating to SPA costs were $0.2 million and $0.5 million. For the
three and nine months ended September 30, 2020, the amounts reimbursed relating to SPA costs were $0.2
million and $0.7
million, respectively.
Amounts
due from Maruho were $3,000 as of September 30, 2021 and were recorded in accounts receivable, related parties in the balance sheets.
There were no amounts due to Maruho at December 31, 2020.
Other
The
Company receives expense reimbursement from Biofrontera AG and Bioscience on quarterly basis for costs incurred on behalf
of these entities, which are netted against expenses incurred within selling, general and administrative expenses. Total expense reimbursements
were $0.2 million and $0.7 million for the three and nine months ended September 30, 2021, respectively. Total expense reimbursements
for the three and nine months ended September 30, 2020 were $0.2 million and $0.6 million, respectively
On
August 27, 2020, the Company received $1.5 million from Pharma to support the Company’s marketing efforts. For
the three and nine months ended September 30, 2020, the Company recorded $0.1 million as a reduction of selling, general and administrative
costs in the statement of operations to offset the $0.1 million of specific, incremental, identifiable marketing costs incurred to support
the sales of Ameluz and of BF-RhodoLED and $1.1 million as a reduction of cost of revenue, related party. The remaining $0.3 million
was recorded as a deferred liability as of September 30, 2020, with the expectation of additional marketing costs to be incurred in the
fourth quarter.
15.
Restructuring costs
We
restructured the business of Cutanea and incurred restructuring costs which were subsequently reimbursed by Maruho. Restructuring costs
primarily relate to Aktipak® discontinuation, personnel costs related to the termination all Cutanea employees, and the
winding down of Cutanea’s operations. For the three and nine months ended September 30, 2021, restructuring costs were incurred
in the amount of $0.2 million and $0.7 million, respectively. For the three and nine months ended September 30, 2020, restructuring costs
were incurred in the amount of $0.2 million and $0.9 million, respectively
As
of September 30, 2021, the Company does not expect to incur additional product discontinuation or personnel costs. As of September 30,
2021, the remaining amount the Company expects to incur related to facility exit costs is $0.1
million. The expected completion date of the
remaining facility exit activities is in the fourth quarter of 2021.
16.
Interest Expense, net
Interest
expense, net consists of the following:
Schedule
of Interest Expense
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
For three months ended
September 30,
|
|
|
For nine months ended
September 30,
|
|
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party interest expense
|
|
$
|
-
|
|
|
$
|
(661
|
)
|
|
$
|
-
|
|
|
$
|
(1,868
|
)
|
Contract asset interest expense
|
|
|
(90
|
)
|
|
|
(90
|
)
|
|
|
(268
|
)
|
|
|
(268
|
)
|
Interest income
|
|
|
4
|
|
|
|
7
|
|
|
|
13
|
|
|
|
23
|
|
Interest expense, net
|
|
$
|
(86
|
)
|
|
$
|
(744
|
)
|
|
$
|
(255
|
)
|
|
$
|
(2,113
|
)
|
Related
party interest expense consists of interest expenses incurred under our Revolving Loan Agreement with Biofrontera AG.
Contract
asset interest expense relates to the $1.7 million contract asset in connection with the $7.3 million start-up cost financing received
from Maruho under the Cutanea acquisition share purchase agreement. The contract asset is amortized on a straight-line basis using a
6% interest rate over the financing arrangement contract term, which ends on December 31, 2023.
17.
Other Income (Expense), net
Other
income (expense), net consists
of the following:
Schedule
of Other Income (Expenses)
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
For three months ended
September 30,
|
|
|
For nine months ended
September 30,
|
|
(in thousands)
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursed SPA costs
|
|
$
|
188
|
|
|
$
|
199
|
|
|
$
|
472
|
|
|
$
|
733
|
|
Other, net
|
|
|
(3
|
)
|
|
|
(35
|
)
|
|
|
(53
|
)
|
|
|
63
|
|
Other income (expense), net
|
|
$
|
185
|
|
|
$
|
164
|
|
|
$
|
419
|
|
|
$
|
796
|
|
Other,
net, primarily includes gain (loss) on foreign currency transactions and gain on termination of operating leases.
18.
Net Loss per Share
Basic
and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands, except share and per share
amounts):
Schedule
of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For three months ended
September 30,
|
|
|
For nine months ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(16,012
|
)
|
|
$
|
(2,985
|
)
|
|
$
|
(23,208
|
)
|
|
$
|
(10,801
|
)
|
Weighted average common shares outstanding, basic and diluted
|
|
|
8,000,000
|
|
|
|
1,000
|
|
|
|
8,000,000
|
|
|
|
1,000
|
|
Net loss per share, basic and diluted
|
|
$
|
(2.00
|
)
|
|
$
|
(2,984.67
|
)
|
|
$
|
(2.90
|
)
|
|
$
|
(10,800.96
|
)
|
19.
Commitment and Contingencies
Facility
Leases
The
Company leases its corporate headquarters under an operating lease that expires in November 2025. The Company provided the landlord with
a security deposit in the amount of $0.1 million, which was recorded as other assets in the balance sheets.
In
connection with the acquisition of Cutanea, the Company inherited various property leases in Pennsylvania, which
were non-cancellable. All Cutanea property leases are operating leases and will end in 2021. A security deposit in the amount of $0.1
million was recorded as prepaid expenses and other current assets at December 31, 2020 and September 30, 2021.
Rent
expense is recorded on a straight-line basis through the end of the lease term. Certain Cutanea office space is subleased to other tenants.
The Company incurred rent expense, net of sublease income, in the amount of $0.2 million and $0.6 million for the three and nine months
ended September 30, 2021, respectively, which was included in selling, general, and administrative expenses and restructuring costs.
The rent expense, net of sublease income, for the three and nine months ended September 30, 2020 was $0.2 million and $0.8 million, respectively.
Auto
Leases
The
Company also leases autos for its field sales force with a lease payment term of 40 months. The Company incurred auto lease expense of
$0.1 million and $0.4 million for the three and nine months ended September 30, 2021, respectively. Auto lease expense for the three
and nine months ended September 30, 2020 was $0.1 million and $0.4 million, respectively.
The
minimum aggregate payments of all future lease commitments, net of future sublease income, at September 30, 2021, are as follows:
Schedule
of Future Commitments and Sublease Income
(in thousands)
|
|
|
|
Years ending December 31,
|
|
Gross future lease commitments
|
|
|
Sublease income
|
|
|
Net future lease commitments
|
|
2021 Remaining
|
|
$
|
372
|
|
|
$
|
(53
|
)
|
|
$
|
319
|
|
2022
|
|
|
709
|
|
|
|
-
|
|
|
|
709
|
|
2023
|
|
|
494
|
|
|
|
-
|
|
|
|
494
|
|
2024
|
|
|
470
|
|
|
|
-
|
|
|
|
470
|
|
2025
|
|
|
352
|
|
|
|
-
|
|
|
|
352
|
|
Total
|
|
$
|
2,397
|
|
|
$
|
(53
|
)
|
|
$
|
2,344
|
|
Cutanea
earnout payments
We
are obligated to repay to Maruho $3.6 million on December 31, 2022 and $3.7 million on December 31, 2023 for start-up cost financing
paid to us in connection with the Cutanea acquisition.
We
are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition
Contract Liabilities.
Milestone
payments with Ferrer Internacional S.A.
Under
the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer
i) $2,000,000 upon the first occasion when annual net sales of Xepi® under the Xepi LSA exceed $25,000,000, and ii) $4,000,000
upon the first occasion annual net sales of Xepi® under the Xepi LSA exceed $50,000,000. No payments were made related
to Xepi® milestones for the three and nine months ended September 30, 2021, or 2020. As of September 30, 2021, we were
unable to estimate the timing or likelihood of achieving these milestones.
Legal
proceedings
At
each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and
reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies. The Company expenses as incurred the costs
related to such legal proceedings. We are a named party to a lawsuit filed March 23, 2018 in the United States District Court for
the District of Massachusetts in which we are alleged to have infringed on certain patents and misappropriated certain trade
secrets. Prior to the closing of the IPO, Biofrontera AG shall be responsible for 100% of the legal fees, costs and expenses
related to this matter. After the closing of the IPO Biofrontera AG and the Company agreed to share the related legal costs at a
rate of 69% and 31%, respectively.
On
November 29, 2021, the Company entered into a settlement and release agreement with the respect to the above mentioned litigation.
In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million to settle the claims
in the litigation. The Company will be responsible for $11.25 million of the aggregate settlement amount, plus interest accrued at a
rate equal to the weekly average 1-year constant maturity Treasury yield, and agreed to pay in three installments, as
follows:
|
●
|
On
the 25th day following the entry into the settlement agreement, the Company will pay 50%
of the aggregate amount it owes;
|
|
●
|
On
the 365th day following the entry into the settlement agreement, the Company will pay 25%
of the aggregate amount it owes; and
|
|
●
|
On
the 730th day following entry into the settlement, the Company will pay 25% of the aggregate
amount it owes.
|
As
of September 30, 2021, we recorded a legal settlement liability in the amount of $11.25 million.
20.
Retirement Plan
The
Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan
covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual
compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary.
During
the three and nine months ended September 30, 2021, matching contribution costs paid by the Company were $59,000 and $0.2 million, respectively.
For the three and nine months ended September 30, 2020, matching contribution costs paid by the Company were $31,000 and $0.2 million.
21.
Subsequent Events
The
Company has evaluated events or transactions that occurred after September 30, 2021 for potential recognition or disclosure through November
30, 2021, which is the date these interim financial statements were available to be issued.
On
October 1, 2021 we entered into an amended employment agreement with Professor Hermann Lübbert, Ph.D. that will become
effective upon (i) the consummation of the offering and (ii) the earlier of either of the following occurrences: (a) the date on which
Biofrontera AG is first deemed not to control us under German law or (b) the day after his last day of employment with Biofrontera AG.
The agreement provides that Prof. Dr. Lübbert will serve as our Executive Chairman and, as long as he remains Chief Executive Officer
of Biofrontera AG, devotes 30% of his working capacity to his responsibilities as Executive Chairman and 70% to his responsibilities
to Biofrontera AG. If his employment with Biofrontera AG is terminated, he may devote a larger percentage of his working capacity (up
to 100%) to the performance of his duties as Executive Chairman, subject to the approval and consent of our board of directors. During
the period following the consummation of the Offering that the amended employment agreement is not effective, we will reimburse Biofrontera
AG for a portion of his salary to be agreed between us and Biofrontera AG. The agreement also addresses the possible scenario in which
Prof. Dr. Lübbert resigns from his position at Biofrontera AG and devotes 100% of his time to his role as Executive Chairman. Upon
his resignation from Biofrontera AG, Prof Dr. Lübbert will receive a salary to be determined and approved by our board of directors
at that time, which will be commensurate with the scope of his responsibilities and appropriate with respect to the Company’s financial
situation. We also agree to allow Prof. Dr. Lübbert to participate in any benefit programs we make available to our employees Prof.
Dr. Lübbert is further eligible to receive an annual target performance bonus of up to 100% of his base salary at the time, based
on certain annual corporate goals and individual performance goals established annually by our board of directors. No bonus will be paid
if our board of directors determines that the target achievement of the respective year was below 70%.
On
October 8, 2021, we entered into a Corrected Amendment to Amended and Restated License and Supply Agreement for Ameluz to change the
purchase price we will pay per unit to Pharma for Ameluz® from 50.0% to an amount to be based on our sales history:
- 50% of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from Pharma during a given Commercial Year (as defined in the Ameluz LSA);
- 40% of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the products we license from Pharma; and
- 30% of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license from Pharma.
The
amendment to the Ameluz LSA also entitles us to take over clinical trial and regulatory work under certain circumstances with respect
to the indications that Biofrontera AG and its consolidated subsidiaries, Pharma, Bioscience, Biofrontera Neuroscience GmbH, and Biofrontera
Development GmbH (collectively, the “Biofrontera Group”) is currently seeking from the FDA (as well as certain
other studies identified in the Corrected Amendment to the Ameluz LSA), most of which are described in the Final Prospectus in the section
titled “—Our Licensors’ Research and Development Programs—Current Clinical Trials for Ameluz® for the U.S.
Market” and subtract the cost of the trials from the transfer price of Ameluz®, but it does not grant that right with respect
to any indications that might be pursued in the future.
On
November 2, 2021, we consummated our IPO of 3,600,000
Units
each consisting of (i) one share of common stock of the Company, par value $0.001
per share and (ii) one warrant of the Company
entitling the holder to purchase one Share at an exercise price of $5.00
per Share. The Warrants are immediately exercisable
upon issuance and are exercisable for a period of five
years after the issuance date. The Shares and
Warrants were issued separately in the offering and may be transferred separately immediately upon issuance. The underwriters exercised
in full their option to purchase up to an additional 540,000
Warrants to cover over-allotments. The Units
were sold at a price of $5.00
per Unit, and the Company estimates the net proceeds
from the IPO to be $15.4
million, after deducting estimated underwriting
discounts and commissions and estimated offering expenses payable by the Company. In connection with the IPO, the Company issued to the
underwriters Unit Purchase Options to purchase, in the aggregate, (a) 108,000
Units and (b) an additional 16,200
Warrants (relating to the underwriters’
exercise of the over-allotment option in full, with respect to the Warrants).
In
connection with the consummation of the IPO, on November 2, 2021, Erica Monaco resigned her position on the board of directors of the
Company and John J. Borer, Beth J. Hoffman, Ph.D, and Loretta M. Wedge, CPA, CCGMA (collectively, the “Directors”) were appointed
to the board of directors of the Company (the “Board”). The Board has determined that each of Dr. Hoffman and Ms. Wedge are
independent directors within the meaning of applicable SEC and Nasdaq rules. Effective November 2, 2021, each of the Directors was appointed
to the Board’s Audit Committee, the Board’s Nominating and Corporate Governance Committee and the Board’s Compensation
Committee.
On
November 2, 2021, the Company filed an Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate”)
with the Secretary of State of the State of Delaware in connection with the IPO. The amendment allowed for a classified board and
the issuance of preferred stock. The Board and sole existing stockholder previously approved the Amended and Restated Certificate
to be effective upon the consummation of the IPO.
On
November 24 and November 26, 2021, investors exercised their warrants to purchase a total of 854,000 shares of common stock at
an exercise price of $5.00 per share, resulting in estimated net proceeds of $3.9 million after deducting underwriting discounts and
commission.
On
November 29, 2021, the Company entered into a settlement and release agreement with respect to the previously mentioned litigation. Refer
to Legal Proceedings section in Note 19 for further details.
On
November 29, 2021, the Company entered into a securities purchase agreement with a single institutional investor for the purchase of
2,857,143 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 2,857,143
shares of common stock, in a private placement. The combined purchase price for one share of common stock (or common stock equivalent)
and a warrant to purchase one share of common stock is $5.25. The warrants have an exercise price of $5.25 per share, will be immediately
exercisable, and will expire five years from the issuance date. The gross proceeds from the private placement offering are expected to
be approximately $15.0 million. The private offering is expected to close on or about December 1, 2021, subject to the satisfaction of
customary closing conditions.